Tissue closure

ABSTRACT

A device for fastening tissue includes (a) a shaft extending longitudinally from a distal end insertable into a body to a proximal end attached to a controller which remains outside of the body, the shaft including a lumen extending therethrough and an opening extending through a wall of a distal portion thereof to open the lumen to an exterior of the shaft; (b) a first roller housed within the lumen adjacent to a first longitudinal edge of the opening such that a rotation of the first roller grasps and draws tissue from the body into the lumen in combination; and (c) a fastening element housed within the lumen adjacent to the opening and movable from a tissue receiving configuration to a tissue gripping configuration.

PRIORITY CLAIM

The present application is a Continuation of U.S. patent applicationSer. No. 16/587,865 filed on Sep. 30, 2019; which is a Continuation ofU.S. patent application Ser. No. 15/246,293 filed on Aug. 24, 2016, nowU.S. Pat. No. 10,470,776; which is a Continuation of U.S. patentapplication Ser. No. 13/241,677 filed on Sep. 23, 2011, now U.S. Pat.No. 9,451,967; which claims priority to U.S. Provisional PatentApplication Ser. No. 61/408,849 filed on Nov. 1, 2010. The disclosuresof the above application(s)/patent(s) are incorporated herewith byreference.

BACKGROUND

The closure of perforations in tissue caused by procedures such as largeintra-luminal resections, is an important capability for advancedminimally invasive procedures. Hemostatic clips are widely used bysurgeons to close small gaps and prevent bleeding. However, largeperforations often cannot be adequately treated with these hemostaticclips.

SUMMARY OF THE INVENTION

The present invention relates to a device for fastening tissue,comprising a shaft extending longitudinally from a distal end insertableinto a living body to a proximal end attached to a controller whichremains outside of the body, the shaft including at least one lumenextending therethrough and an elongated opening extending through a wallof a distal portion thereof to open the lumen to an exterior of theshaft and a first roller housed within the lumen adjacent to a firstlongitudinal edge of the opening such that a rotation of the firstroller grasps and draws tissue into the lumen via the opening incombination with a fastening element housed within the lumen adjacent tothe opening and movable from a tissue receiving configuration to atissue fastening configuration.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of a distal portion of a deviceaccording to a first exemplary embodiment of the present invention;

FIG. 2 shows a cross-sectional view of the distal portion of the deviceof FIG. 1 , along line A-A;

FIG. 3 shows a side view of a clip according to an alternate embodimentof the present invention;

FIG. 4 shows a perspective view of a distal portion of a deviceaccording to a second exemplary embodiment of the present invention;

FIG. 5 shows a cross-sectional view of the distal portion of the deviceof FIG. 4 , along line B-B;

FIG. 6 shows a perspective view of a distal portion of a deviceaccording to a third exemplary embodiment of the present invention;

FIG. 7 shows a perspective view of a distal portion of a deviceaccording to a fourth exemplary embodiment of the present invention;

FIG. 8 shows a cross-sectional view of the distal portion of the deviceof FIG. 7 in a first configuration, along line C-C;

FIG. 9 shows a cross-sectional view of the distal portion of the deviceof FIG. 7 , in a second configuration; and

FIG. 10 shows a perspective view of a fastener of the device of FIG. 7 ,according to an alternate embodiment of the present invention.

DETAILED DESCRIPTION

The present invention may be further understood with reference to thefollowing description and the appended drawings, wherein like elementsare referred to with the same reference numerals. The present inventionrelates to devices for tissue approximation and, in particular, relatesto devices for fastening tissue. Exemplary embodiments of the presentinvention describe a device including rollers that draw edges of tissuetogether such that the approximated edges of the perforation may beclipped and/or sutured together. Although exemplary embodiments of thepresent invention specifically describe devices for clipping andfastening perforations, it will be understood by those of skill in theart that the present invention may be similarly used to clip ducts,blood vessels and airways, etc.

As shown in FIGS. 1-2 , a device 100 according to a first exemplaryembodiment of the present invention comprises a shaft 102 including alumen 104 extending longitudinally therethrough. The shaft 102 includesan opening 106 extending laterally through a wall 128 of a distalportion 108 through which edges of a perforation are drawn into thelumen 104. The opening 106 may be configured as, for example, a windowor a slot extending through the wall 28. The device 100 furthercomprises first and second rollers 110, 112 housed within the lumen 104for drawing tissue 150 therein through the opening 106 and a clip 114clipping the edges of the tissue 150 together once the tissue 150 hasbeen drawn into the lumen 104 in contact with one another. As would beunderstood by those skilled in the art, a proximal end of the shaft 102may be coupled to a handle, control mechanism and/or actuating mechanism(not shown) for actuating a rolling mechanism of the pair of rollers110, 112 and for moving the clip 114 from a first configuration to asecond configuration. The distal portion 108 is inserted into a livingbody while the proximal end of the shaft 102 remains outside of thebody. The proximal end of the shaft 102 may be coupled to a vacuumsource for applying a suctioning force through the opening 106 to drawedges of tissue adjacent thereto between the rollers 110, 112. However,those skilled in the art will understand that other mechanisms such as,for example, graspers, may be employed to draw tissue into the opening106.

The opening 106 may be elongated, extending longitudinally along thedistal portion 108 a distance greater than a width thereof (i.e., anextent of the opening 106 around a circumference of the shaft 102). Thefirst and second rollers 110, 112 are housed within the lumen 104 withthe first roller 110 positioned adjacent a first longitudinal edge 116of the opening 106 while the second roller 112 is positioned adjacent toa second longitudinal edge 118 of the opening 106 opposite the firstroller 110. The first and second rollers 110, 112 are spaced apart fromone another by a distance selected to permit the tissue 150 to be drawnat least partially into a space therebetween through the application ofnegative pressure via the lumen 104. The first and second rollers 110,112 may also include a plurality of openings extending through a wallthereof such that a negative pressure may also be applied through therollers 110, 112 to both pull tissue into the opening 106 and to createa grip on the tissue. In another embodiment, at least one of the rollers110, 112 may extend slightly through the opening 106 so that the roller110, 112 functions as a tissue grasper, drawing the tissue 150 throughthe opening 106. The rollers 110, 112 are attached to an actuatingmechanism (not shown) (e.g., at the proximal end of the shaft 102) viadrive shafts that rotate the rollers 110, 112 in the direction of arrowsA with portions of the rollers 110, 112 adjacent to the opening 106rotating toward the center of the lumen 104 to draw edges of tissuepositioned between the rollers 110, 112 further into the lumen 104between the rollers 110, 112, as shown in FIG. 2 . In a furtherembodiment, the rollers 110, 112 may be moved relative to one another toadjust the space therebetween. For example, an initial space between therollers 110, 112 may be selected to permit tissue to be drawntherebetween. Once tissue has been drawn between the rollers 110, 112,as desired, the rollers 110, 112 may be moved toward one another toreduce the amount of space therebetween, holding the tissue 150therebetween for fastening.

The outer surface of one or both of the rollers 110, 112 may be treatedto increase friction against the tissue 150. For example, the outersurface may be treated to increase friction against the tissue 150. Forexample, at least one of the rollers 110, 112 may be treated to includea coating with a non-slip material or a coating that roughens a surfacethereof. Alternatively, the outer surface may include tissue grippingfeatures such as, for example, barbs, teeth, divots and spikes, whichfacilitate a gripping and/or pulling of the tissue 150. Although tworollers 110, 112 are specifically described herein, it will beunderstood by those of skill in the art that the device 100 mayalternatively include a single roller positioned adjacent an edge of theopening 106 to draw tissue therein as the roller rotates.

The fastener 114 is housed within the lumen 104 and is movable between afirst configuration in which the fastener 114 is positioned proximallyof the rollers 110, 112 and a second configuration in which the fastener114 is moved distally relative to the shaft 102 to fastener the tissue150 approximated by the rollers 110, 112. The fastener 114 may beconnected to the actuator at the proximal end of the shaft 102 via forexample, a pusher 115 which pushes the fastener 114 from the firstconfiguration to the second configuration. The exemplary fastener 114includes a plurality of arms 120 configured to grip the approximatededges of tissue therebetween. However, those skilled in the art willunderstand that fasteners of any number of configurations may beemployed without departing from the scope of the invention. A length ofthe arms 120 may be selected to be at least as long as a length of atissue attachment site such as, for example, a perforation, so thatedges of the tissue may be entirely gripped therebetween allowing thetissue attachment site to be entirely sealed with a single fastener 114.

In one exemplary embodiment, the fastener 114 is formed of an elastic,spring-like material with the arms 120 biased toward a clippingconfiguration in which the arms 120 are separated by a distancecorresponding to a thickness of the edges of the tissue 150 to begripped thereby. That is, the arms may be biased toward a position inwhich, when a target thickness of tissue is received therebetween, thearms 120 exert a desired clipping force to the tissue while theelasticity of the arms 120 permits the arms to spread apart slightly asthey are deployed over the tissue 150 allowing the tissue to be slidinto the fastener 114. Thus, the size of a space 122 between the arms120 when the fastener 114 is in an unstressed state is sized tofacilitate both receipt of the tissue 150 and to achieve a desiredgripping force after the tissue has been properly positioned within thefastener 114.

In another embodiment, as shown in FIG. 3 , a fastener 114′ may includea plurality of arms 120′ biased toward an open configuration to receivethe approximated edges of tissue 150 therebetween. The fastener 114′ mayinclude a locking mechanism 124′ at a distal end 126′ thereof. The arms120′ may be moved toward one another and the locking mechanism 124′ maybe locked to lock the arms 120′ relative to one another, fixing thetissue therebetween after the tissue has been positioned as desiredbetween the arms 120′. The locking mechanism 124′ may include, forexample, a first coupling element at a distal end of a first arm 120′and a second coupling element at a distal end of a second arm 120′,which are configured to couple to one another. In some cases, wheretissue extends beyond a distal end of the fastener 114′, the firstcoupling element may be capable of penetrating tissue to connect to thesecond connecting element. Once tissue has been positioned between thearms 120′ as desired, the arms 120′ may be drawn together via, forexample, a capture sleeve deployed to move over the arms 120′, anexternal grasping mechanism, a clamping mechanism or a spring mechanism.

An exemplary tissue fastening technique according to the presentinvention, includes insertion of the device 100 into a living body(e.g., via a naturally occurring bodily orifice) such until the distalportion 108 is adjacent a tissue perforation to be treated. A vacuumsource may then be activated to apply a vacuum force through the lumen104 drawing edges of the perforation through the opening 106 inproximity to the rollers 110, 112. The rollers 110, 112 may then beactuated so that the rollers 110, 112 rotate inward relative to oneanother to draw the edges of the tissue 150 therebetween into the lumen104 gripping the tissue 150 between the rollers 110, 112. Once the edges150 are gripped between the rollers 110, 112, as desired, theapproximated edges 150 are fastened together via the fastener 114, whichis moved to the second configuration with the approximated edges 150slidably received between the arms 120 thereof. The arms 120 fasten theedges together, providing closure of the perforation. Where the fastener114′ is used, the lock 124′ may be locked such that the arms 120′ arefixed relative to one another and the tissue 150 is permanently grippedtherebetween. Upon closure of the perforation, the shaft 102 may beremoved from the body leaving the fastener 114 in position over thefastened tissue. The fastener 114 may remain in the body eithertemporarily or permanently. The fastener 114 may be resorbable oreventually fall off after healing of the perforation. Alternatively, thefastener 114 may be surgically removed after healing.

As shown in FIGS. 4-5 , a device 200 according to another exemplary isbe substantially similar to the device 100, comprising a shaft 202including a lumen 204 extending therethrough. The shaft 202 furtherincludes a longitudinally shaped opening 206 extending laterally througha wall 228 of a distal portion 208 thereof with rollers 210, 212positioned adjacent to the opening 206 similarly to the rollers 110, 112of the device 100 described above. The device 200, however, includes aneedle 214 rather than a fastener. In addition, the rollers 210, 212have outer surfaces 230, 232, respectively, that are complementary suchthat tissue received therebetween is shaped into folds. A raised portionalong the outer surface 230 of the first roller may correspond to agrooved portion along the outer surface 232 of the second roller 212such that the tissue drawn therebetween includes a fold along a lengththereof. For example, the outer surfaces 230, 232 may correspondinglyextend in a sinusoidal, wave-like pattern along a length thereof suchthat a peak of the first roller 210 corresponds to a trough of thesecond roller 212. Thus, as the rollers 210, 212 are rotated inwardrelative to one another, edges of the tissue 250 are drawn therebetweenin a corresponding wave-like pattern such that the tissue 250 includesfolds along a length thereof, as shown in FIG. 4 .

A needle 214 may be substantially straight including a filament suchthat advancement of the needle 214 distally relative to the shaft 202passes the needle 214 through the folds of the approximated tissue 250,fastening the approximated edges together. The filament may be, forexample, a wire, a suture thread, etc. The needle 214 may be moveddistally via, for example, a push mechanism, which advances the needlethrough the tissue 250. The needle 214 may extend distally past a distalend of the tissue 250 such that the filament extends through the foldsof the tissue 250, securing the edges of the tissue 250 together. Theneedle 214 may be captured at distal end of the device 200. Beads, stopsor other locking elements may be affixed to the proximal and/or distalends of the filament to hold the filament within the tissue and/orpermit a desired tension to be applied on the filament. Alternatively,the filament may be cut and fastened via, for example, a surgical knot.It will be understood by those of skill in the art that the device mayadditionally include a cutting mechanism configured to cut the filamentafter the edges of the tissue have been secured. Alternatively, acutting tool may be passed down to the surgical site. The surgical knotapplied to the filament may be, for example, a pusher knot in whichfilament ends are retracted out of the body, knotted, and then advancedback to the tissue. The filament may be formed of any knownbiocompatible and/or resorbable material so that the suture may remainin place or dissolve over time. In an alternative embodiment, the needle214 itself may be used as the fastener so that a filament is notrequired. The needle 214 is passed through the folds of the tissue 250and is held therein via, for example, any of the locking elementsdescribed above. Similarly, the needle 214 may remain in place, dissolveor degrade over time. The needle 214 may be formed of a material that isstiff upon deployment to pass through the tissue 250, but which softensover time.

As shown in FIG. 6 a device 300 according to another embodiment may besubstantially similar to the device 100, as described above, comprisinga shaft 302 including a lumen 304 extending therethrough. Similarly tothe device 100, a distal portion 308 of the shaft 302 includes a opening306 through which tissue may be drawn into the lumen 304. The device300, however, does not include rollers for drawings tissue therein.Rather, the device 300 includes one or more tissue graspers 310, whichare controllable via a control mechanism attached to a proximal end ofthe shaft 302. The tissue graspers 310 may include jaws 311 movablerelative to one another to grasp tissue therebetween as would beunderstood by those skilled in the art. In another embodiment, thetissue graspers 310 may include hooks or other tissue grasping elements.Once the distal portion 308 has been positioned adjacent a penetrationin a target portion tissue, the tissue graspers 310 are moved out of theopening 306 to grasp the edges of the tissue, drawing the edges togetherinto the lumen 304. As described above in regard to device 100, a vacuumforce may be applied through the lumen 304 to assist in drawing theedges of the tissue toward the opening 306 facilitating grasping of theedges by the tissue grasper 310. In another embodiment, the tissuegrasper 310 may be a vacuum grasper separate from the vacuum in theshaft 302. The vacuum grasper may include, for example, a vacuum lineand a flexible cup at a distal end thereof for grasping tissue via avacuum force exerted through the vacuum line.

Once the target tissue has been drawn into the lumen 304 via the opening306, a fastener 314 is moved distally within shaft 302 to fasten theapproximated edges together. The fastener 314 may be substantiallysimilar to any of the fastener configurations described above in regardto the device 100. Those skilled in the art will understand that any ofthe fasteners described in regard to this invention may alternatively behoused in a portion of the shaft distal to the opening and movedproximally over the tissue drawn into the lumen to fasten the targettissue.

As shown in FIGS. 7-9 , a device 400 according to another embodiment ofthe present invention may be substantially similar to the device 100, asdescribed above, comprising a shaft 402 including a lumen 404 extendinglongitudinally therethrough and a opening 406 extending transverselythrough a wall 428 of a distal portion 408 thereof. Rather than rollersand a fastener including arms, however, the device 400 comprises afastener 414 housed within the distal portion 408 of the shaft 402. Thefastener 414 is curved along a longitudinal axis thereof such thattarget tissue may be received between longitudinal edges 410, 412 of thefastener 414. The longitudinal edges 410, 412 are movable between afirst tissue receiving configuration, as shown in FIG. 8 , and a secondtissue gripping configuration, as shown in FIG. 9 . Similarly to therollers 110, 112 in the device 100, the first longitudinal edge 410 ofthe fastener 414 may be positioned adjacent a first longitudinal edge416 of the opening 406 and the second longitudinal edge 412 may bepositioned adjacent a second longitudinal edge 418 of the opening 406.Thus, as tissue is drawn through the opening 406 into the lumen 404, thetissue is received between the longitudinal edges 410, 412 of thefastener 414.

The fastener 414 may be a spring clip formed of a shape memory materialwhich, when activated, moves from the first configuration to the secondconfiguration. The fastener 414 may be activated by, for example,providing mechanical or electrical stimulation. Activation of thefastener 414 moves the fastener 414 from the first configuration inwhich the longitudinal edges 410, 412 thereof are spaced apart in atissue receiving configuration, to the second configuration in which thelongitudinal edges 410, 412 are moved toward one another to fastentissue therebetween. In another embodiment, the fastener 414 may beformed of an elastic or superelastic material that is held open whiletissue is drawn between the longitudinal edges 410, 412 thereof andsnapped shut when the holding force is removed. The tissue may be drawninto the opening 406 using any known method such as a suctioning force,tissue graspers, etc. In a further embodiment, the longitudinal edges410, 412 may be shaped to roll inward with respect to one another, asshown in FIG. 9 so that tissue drawn toward the opening 406 via, forexample, a suctioning force, is gripped and drawn between the inwardlyrolling edges 410, 412 as the fastener 414 is activated and moved to thesecond configuration. In another embodiment, as shown in FIG. 10 , thefastener 414′ may be plastically deformed such that longitudinal edges410′, 412′ roll inward via a tubular die 430′ that is moved over thefastener 414′. The tubular die 430′ tapers from a first end 432′ to asecond end 434′ and includes an edge 436′ that is curled inward along alength thereof. The edge 436′ may correspond to a desired curvature ofthe longitudinal edges 410′, 412′ in the second configuration such thatas the tubular die 430′ is moved over the fastener 414′, thelongitudinal edges 410′, 412′ are moved from the first configuration tothe second configuration. It will be understood by those of skill in theart, however, that the fastener 414 may be any type of locking fastenerformed of any material such as an elastic, superelastic and/or plasticmaterial, that permits the fastener 414 to be moved from the firstconfiguration to the second configuration. To enhance the grippingcapabilities of the edges 410, 412 of the fastener 414, the edges 410,412 may include teeth, serrations or other elements to facilitategripping of the tissue. The edges 410, 412 may also be treated with acoating to facilitate gripping by, for example, roughening a surfacethereof.

It will be understood by those skilled in the art that variousmodifications and variations can be made in the structure and themethodology of the present intention, without departing from the spiritor scope of the invention. Thus, it is intended that the presentinvention cover the medications and variations of this inventionprovided that they come within the scope of the appended claims andtheir equivalents.

1-27. (canceled)
 28. A method for closing a tissue opening, comprising the steps of: inserting into a living body a distal portion of a shaft and positioning a tissue receiving opening extending through a wall of the shaft adjacent to the tissue opening, the shaft extending longitudinally from a distal end to a proximal end attached to a controller which remains outside of the body and including a lumen extending therethrough; drawing edges of the tissue opening through the tissue receiving opening into the lumen; and moving a fastening element housed within the lumen from a first configuration in which the fastening element is open to receive the tissue edges therebetween to a second configuration in which the fastening element is closed to fasten the tissue edges against one another.
 29. The method of claim 28, further comprising the step of grasping the tissue edges with a tissue grasper to draw the tissue edges farther into the lumen.
 30. The method of claim 28, wherein the fastening element includes a tubular spring clip including a longitudinal opening and curved along a longitudinal axis thereof with a first fastening edge of the spring clip positioned adjacent a first longitudinal edge of the tissue opening and a second fastening edge of the spring clip positioned along a second longitudinal edge of the tissue opening, the first and second fastening edges being spaced apart in the first configuration to receive the tissue edges therebetween and moved together in the second configuration to fasten the tissue edges together.
 31. The method of claim 30, further comprising the step of moving a tubular die along a longitudinal axis of the spring clip to force the first and second fastening edges to roll inward from the first configuration to the second configuration.
 32. The method of claim 31, wherein the tubular die tapers from a first end to a second end and includes an edge curled inward along a length thereof, the edge corresponding to a desired curvature of the first and second fastening edges in the second configuration.
 33. The method of claim 30, wherein the spring clip includes a shape memory material, further comprising the step of activating the spring clip to revert to a memorized shape via one of mechanical and electrical stimulation to move the spring clip from the first configuration to the second configuration.
 34. The method of claim 30, wherein the first and second fastening edges include a plurality of gripping features to facilitate gripping of the tissue edges.
 35. The method of claim 34, wherein the gripping features include at least one of teeth, protrusions and serrations.
 36. The method of claim 34, wherein the gripping features include a coating enhancing frictional engagement between the first and second fastening edges and the tissue edges.
 37. The method of claim 28, wherein the step of drawing tissue into the lumen includes applying a vacuum force through the lumen of the shaft to draw the target tissue through the tissue receiving opening.
 38. The method of claim 28, wherein the fastening element includes an elastic clip including a longitudinal opening curved along a longitudinal axis thereof with a first fastening edge of the elastic clip positioned adjacent a first longitudinal edge of the tissue opening and a second fastening edge of the elastic clip positioned along a second longitudinal edge of the tissue opening, the first and second fastening edges being spaced apart in the first configuration to receive the tissue edges therebetween and moved together in the second configuration to fasten the tissue edges together, the elastic clip including a removable holding element which, when received between the first and second fastening edges, holds the elastic clip in the first configuration, further comprising the step of removing the holding element to permit the elastic clip to move to the second configuration.
 39. The method of claim 38, wherein the elastic clip includes a shape memory material, further comprising the step of activating the elastic clip to revert to a memorized shape via one of mechanical and electrical stimulation to move the elastic clip from the first configuration to the second configuration.
 40. The method of claim 38, wherein the first and second fastening edges include a plurality of gripping features to facilitate gripping of the tissue edges.
 41. The method of claim 40, wherein the gripping features include at least one of teeth, protrusions and serrations.
 42. The method of claim 40, wherein the gripping features include a coating enhancing frictional engagement between the first and second fastening edges and the tissue edges. 